Capstone Therapeutics Announces Continuation of AZX100 Phase 2 Clinical Trial in Dermal Scarring Following Shoulder Surgery
TEMPE, Ariz., Jul 6, 2010 (GlobeNewswire via COMTEX News Network) -- Capstone Therapeutics (Nasdaq:CAPS) announced today it has completed a limited analysis of a subset of data from its ongoing AZX100 Phase 2a clinical trial in trocar site scarring following arthroscopic shoulder surgery. Based on this analysis, the clinical trial will continue to its planned 12-month endpoints.
The company's goals for this analysis were to assess AZX100 ongoing safety, to evaluate the quality of the clinical trial dataset in order to guide future studies and to determine whether continuation of the trial would be futile from a statistical perspective.
"We have met our objectives for this preliminary analysis of our trocar site scarring trial," said Randolph C. Steer, MD, PhD, President of Capstone Therapeutics. "Following a limited review of the data by an independent statistician examining AZX100 safety and the quality of the dataset, we have been advised to continue the trial. The primary endpoint is the 12-month POSAS score; secondary endpoints include a series of independently-analyzed, validated, objective measurements of the scar throughout the 12-month post-surgical period. We expect to report data from this trial during 1Q2011."
Dermal scars result primarily from elective surgery (hospital and minor/office based), cosmetic, plastic and reconstructive surgery and trauma (including accidents, emergency and burns). Scars - especially exuberant, hypertrophic scars - can cause debilitating aesthetic, functional and psychological effects and remain a significant area of unmet medical need. Market research indicates there may be as many as 22.5 million surgical procedures performed annually in the U.S. that could produce some form of scarring. There are currently no prescription medications indicated for reduction of dermal scarring marketed in the U.S. or Europe.
About the Study
The ongoing AZX100 Phase 2 clinical trial in trocar site scarring (OL-ASCAR-03) is a double-blind, placebo within-patient controlled, multi-center dose ranging study to evaluate the safety and preliminary efficacy of AZX100 in trocar sites of subjects who have undergone arthroscopic shoulder surgery. The primary objective of the study is to evaluate the efficacy of AZX100 based on the differences among dosage groups (3.0 mg, 10.0 mg, placebo) in Patient and Observer Scar Assessment Scale (POSAS) scores at 12 months. Secondary objectives include safety determination and evaluations of efficacy via independent, validated scar assessment scales using state-of-the-art 2D and 3D high-resolution digital photography. For each patient, each of three trocar sites (e.g., anterior, lateral, and posterior sides of shoulder) were randomized to receive one of two doses of AZX100 (3.0 mg, 10.0 mg) or placebo. All trocar sites received one administration of a study agent at 9 +/- 2 days after surgery and a second administration of the same study agent 21 +/- 2 days after surgery. One hundred fifty subjects were dosed in the trial. The study protocol specified that a planned subset of 25 subjects be randomized to receive only placebo injections after their surgeries following the same administration schedule as the other cohorts. The analysis reported today examined certain metrics from a subset of dosed subjects followed for seven months post-surgery.
About Capstone Therapeutics
Capstone Therapeutics Corp. (formerly OrthoLogic Corp.) is a biotechnology company committed to developing a pipeline of novel therapeutic peptides aimed at helping patients with under-served medical conditions. The Company is focused on development and commercialization of two product platforms: AZX100 and Chrysalin (rusalatide acetate or TP508).
AZX100 is a novel synthetic 24-amino acid peptide, one of a new class of compounds in the field of smooth muscle relaxation and fibrosis. Based on its demonstrated effects in pre-clinical models and safety in clinical trials, AZX100 is currently being evaluated for commercially significant medical applications such as the prevention or reduction of hypertrophic and keloid scarring, treatment of pulmonary fibrosis and intimal hyperplasia. Capstone has an exclusive worldwide license to AZX100.
Chrysalin, the Company's novel synthetic 23-amino acid peptide, has been proven in multiple pre-clinical and clinical models to stimulate cellular events leading to angiogenesis, revascularization, and repair of dermal and musculoskeletal tissues. It is currently being evaluated in disorders that involve vascular endothelial dysfunction, such as acute myocardial infarction and chronic myocardial ischemia. The Company owns exclusive worldwide rights to Chrysalin.
Capstone's corporate headquarters are in Tempe, Arizona. For more information, please visit the Company's website: www.capstonethx.com.
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Statements in this press release or otherwise attributable to Capstone regarding our business that are not historical facts are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include the timing and acceptability of FDA filings and the efficacy and marketability of potential products, involve risks and uncertainties that could cause actual results to differ materially from predicted results. These risks include: delays in obtaining or inability to obtain FDA, institutional review board or other regulatory approvals of pre-clinical or clinical testing; unfavorable outcomes in our pre-clinical and clinical testing; the development by others of competing technologies and therapeutics that may have greater efficacy or lower cost; delays in obtaining or inability to obtain FDA or other necessary regulatory approval of our products; our inability to successfully and cost effectively develop or outsource manufacturing and marketing of any products we are able to bring to market; changes in FDA or other regulations that affect our ability to obtain regulatory approval of our products, increase our manufacturing costs or limit our ability to market our product; effects of the Capstone Stockholder Put Right on our stock price, liquidity or our ability to continue operations; effects on our stock price and liquidity if we are unable to meet the requirements for continued listing on the Nasdaq Capital Market; our need for additional capital in the future to fund the continued development of our product candidates; and other factors discussed in our Form 10-K for the fiscal year ended December 31, 2009, and other documents we file with the Securities and Exchange Commission.
Editor's Note: This press release is also available under the Investors section of the Company's website at www.capstonethx.com.
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SOURCE: Capstone Therapeutics
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